BEUDAMED
    2 results · 9ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ ECi/ECiQ Immunodiagnostic Systems, VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600 Integrated Systems for the quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma.

    FDA Enforcement
    Class II ·Terminated·ORTHO-CLINICAL DIAGNOSTICS·August 20, 2014

    Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025